Trial Outcomes & Findings for ATI-450 vs Placebo in Participants With Moderate to Severe Hidradenitis Suppurativa (HS) (NCT NCT05216224)
NCT ID: NCT05216224
Last Updated: 2026-01-07
Results Overview
AN count was the sum of number of abscess and inflammatory nodules across anatomical regions. The least square (LS) mean change from baseline in the count at Week 12 was estimated from the Mixed Model Repeated Measures (MMRM) model.
COMPLETED
PHASE2
95 participants
Baseline, Week 12
2026-01-07
Participant Flow
Participant milestones
| Measure |
ATI-450
Participants received a single oral tablet of ATI-450 50 milligrams (mg) twice daily (BID) for 12 weeks.
|
Placebo
Participants received a single oral tablet of Placebo BID for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
47
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
48
|
47
|
|
Overall Study
COMPLETED
|
25
|
32
|
|
Overall Study
NOT COMPLETED
|
23
|
15
|
Reasons for withdrawal
| Measure |
ATI-450
Participants received a single oral tablet of ATI-450 50 milligrams (mg) twice daily (BID) for 12 weeks.
|
Placebo
Participants received a single oral tablet of Placebo BID for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
8
|
6
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
|
Overall Study
Other than specified
|
1
|
0
|
Baseline Characteristics
ATI-450 vs Placebo in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
Baseline characteristics by cohort
| Measure |
ATI-450
n=48 Participants
Participants received a single oral tablet of ATI-450 50 mg BID for 12 weeks.
|
Placebo
n=47 Participants
Participants received a single oral tablet of Placebo BID for 12 weeks.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 9.87 • n=37 Participants
|
36.6 years
STANDARD_DEVIATION 9.32 • n=56 Participants
|
35.9 years
STANDARD_DEVIATION 9.58 • n=95 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=37 Participants
|
40 Participants
n=56 Participants
|
79 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=37 Participants
|
7 Participants
n=56 Participants
|
16 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=37 Participants
|
8 Participants
n=56 Participants
|
18 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=37 Participants
|
39 Participants
n=56 Participants
|
77 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=37 Participants
|
20 Participants
n=56 Participants
|
38 Participants
n=95 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=37 Participants
|
27 Participants
n=56 Participants
|
55 Participants
n=95 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=95 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: FAS population: All participants who were randomized and administered at least 1 dose of study drug.
AN count was the sum of number of abscess and inflammatory nodules across anatomical regions. The least square (LS) mean change from baseline in the count at Week 12 was estimated from the Mixed Model Repeated Measures (MMRM) model.
Outcome measures
| Measure |
ATI-450
n=48 Participants
Participants received a single oral tablet of ATI-450 50 mg BID for 12 weeks.
|
Placebo
n=47 Participants
Participants received a single oral tablet of Placebo BID for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 12
|
-2.93 AN count
Interval -3.99 to -1.87
|
-5.94 AN count
Interval -7.01 to -4.87
|
SECONDARY outcome
Timeframe: Week 12Population: FAS population: All participants who were randomized and administered at least 1 dose of study drug.
HiSCR50 Achiever was defined as a participant having a ≥50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase in the number of abscesses, and no increase in the number of draining fistula counts from baseline. A participant was considered an achiever only if all 3 criteria mentioned above were fulfilled. Model-based estimates and 90% confidence intervals (CIs) were produced. Firth's penalized likelihood logistic regression model with fixed effects for treatment and baseline count of inflammatory abscesses and nodules was used.
Outcome measures
| Measure |
ATI-450
n=48 Participants
Participants received a single oral tablet of ATI-450 50 mg BID for 12 weeks.
|
Placebo
n=47 Participants
Participants received a single oral tablet of Placebo BID for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 12
|
31.5 percentage of participants
Interval 21.6 to 43.4
|
51.4 percentage of participants
Interval 39.5 to 63.2
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS population: All participants who were randomized and administered at least 1 dose of study drug.
The IHS-4 is a validated tool used to access the HS severity and is calculated based on the clinical signs of HS: inflammatory nodules, abscesses and draining tunnels (fistulas and sinuses). The IHS-4 score = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + (number of draining tunnels \[fistulas/sinuses\] multiplied by 4). Mild HS is a score of 3 or less, moderate HS is a score of 4-10, and severe HS is a score of 11 or higher. A decrease in score means less severity.
Outcome measures
| Measure |
ATI-450
n=48 Participants
Participants received a single oral tablet of ATI-450 50 mg BID for 12 weeks.
|
Placebo
n=47 Participants
Participants received a single oral tablet of Placebo BID for 12 weeks.
|
|---|---|---|
|
Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS-4) at Week 12
|
-4.01 units on a scale
Interval -6.31 to -1.71
|
-11.86 units on a scale
Interval -14.18 to -9.53
|
SECONDARY outcome
Timeframe: Week 12Population: Only participants in the FAS population with a baseline NRS-PGA -SP ≥3 were evaluated for this outcome measure.
NRS30 Achiever was defined as participants achieving at least a 30% reduction from baseline in Patient's Global Assessment of Skin Pain (PGA-SP) and at least 1 unit reduction from baseline in PGA-SP at Week 12 among participants with baseline PGA-SP ≥3. Model-based estimates and 90% CIs were produced. Firth's penalized likelihood logistic regression model with fixed effects for treatment and baseline PGA-SP was used.
Outcome measures
| Measure |
ATI-450
n=37 Participants
Participants received a single oral tablet of ATI-450 50 mg BID for 12 weeks.
|
Placebo
n=38 Participants
Participants received a single oral tablet of Placebo BID for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving NRS30
|
43.7 percentage of participants
Interval 30.9 to 57.3
|
57.5 percentage of participants
Interval 44.0 to 69.9
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS population: All participants who were randomized and administered at least 1 dose of study drug.
In the HS-PGA scale, the Investigators rated the counts of nodules (inflammatory and non-inflammatory) abscesses and fistulas (both draining and nondraining) and assigned a participant to 1 of 6 categories ranging from clear (0) to very severe (5). A decrease in score means a better outcome.
Outcome measures
| Measure |
ATI-450
n=48 Participants
Participants received a single oral tablet of ATI-450 50 mg BID for 12 weeks.
|
Placebo
n=47 Participants
Participants received a single oral tablet of Placebo BID for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HSPGA) at Week 12
|
-0.31 units on a scale
Interval -0.48 to -0.14
|
-0.73 units on a scale
Interval -0.9 to -0.55
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS population: All participants who were randomized and administered at least 1 dose of study drug.
The DLQI is a 10-item validated questionnaire used to assess the impact of HS disease symptoms and treatment on quality of life (QoL). It consists of questions including a single "yes/no" question and questions with possible responses of "not at all," "a little," "a lot," or "very much." These questions evaluate the impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each question was scored using a 4-point scale ranging from 0 to 3 based on a participant's response: not at all/not relevant (0), a little (1), a lot (2) and very much (3). The total score of the DLQI ranged from 0 to 30 and was calculated by adding up the scores from each question. The higher the score, the greater the impact on a participant's QoL.
Outcome measures
| Measure |
ATI-450
n=48 Participants
Participants received a single oral tablet of ATI-450 50 mg BID for 12 weeks.
|
Placebo
n=47 Participants
Participants received a single oral tablet of Placebo BID for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12
|
-3.27 units on a scale
Interval -4.66 to -1.89
|
-4.08 units on a scale
Interval -5.48 to -2.68
|
SECONDARY outcome
Timeframe: Baseline through Day 115Population: Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
TEAEs are defined as AEs with an onset date on or after the date of first administration of study drug and before the date of last administration of study drug + 30 days. A summary of non-serious AEs and serious AEs, regardless of causality is located in Reported AEs section.
Outcome measures
| Measure |
ATI-450
n=48 Participants
Participants received a single oral tablet of ATI-450 50 mg BID for 12 weeks.
|
Placebo
n=47 Participants
Participants received a single oral tablet of Placebo BID for 12 weeks.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
35 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 2 hours postdose on Days 1, 8, and 85Population: Pharmacokinetic (PK) population: All participants who were randomized, took at least 1 dose of study drug, and had at least 1 evaluable PK assay. Here, 'Number analyzed' = participants evaluable for specified category.
Outcome measures
| Measure |
ATI-450
n=48 Participants
Participants received a single oral tablet of ATI-450 50 mg BID for 12 weeks.
|
Placebo
n=47 Participants
Participants received a single oral tablet of Placebo BID for 12 weeks.
|
|---|---|---|
|
ATI-450 and Metabolite (CDD-2164) Concentrations
ATI-450 Day 1
|
144.995 Nanograms per milliliter (ng/ml)
Standard Deviation 62.7707
|
0.623 Nanograms per milliliter (ng/ml)
Standard Deviation 1.2728
|
|
ATI-450 and Metabolite (CDD-2164) Concentrations
ATI-450 Day 8
|
207.571 Nanograms per milliliter (ng/ml)
Standard Deviation 98.0314
|
0.504 Nanograms per milliliter (ng/ml)
Standard Deviation 1.2063
|
|
ATI-450 and Metabolite (CDD-2164) Concentrations
ATI-450 Day 85
|
232.110 Nanograms per milliliter (ng/ml)
Standard Deviation 116.3028
|
0.250 Nanograms per milliliter (ng/ml)
Standard Deviation 0.000
|
|
ATI-450 and Metabolite (CDD-2164) Concentrations
CDD-2164 Day 8
|
63.632 Nanograms per milliliter (ng/ml)
Standard Deviation 32.1682
|
0.277 Nanograms per milliliter (ng/ml)
Standard Deviation 0.1231
|
|
ATI-450 and Metabolite (CDD-2164) Concentrations
CDD-2164 Day 1
|
49.741 Nanograms per milliliter (ng/ml)
Standard Deviation 26.7662
|
0.364 Nanograms per milliliter (ng/ml)
Standard Deviation 0.3932
|
|
ATI-450 and Metabolite (CDD-2164) Concentrations
CDD-2164 Day 85
|
70.698 Nanograms per milliliter (ng/ml)
Standard Deviation 34.0962
|
0.250 Nanograms per milliliter (ng/ml)
Standard Deviation 0.000
|
Adverse Events
ATI-450
Placebo
Serious adverse events
| Measure |
ATI-450
n=48 participants at risk
Participants received a single oral tablet of ATI-450 50 mg BID for 12 weeks.
|
Placebo
n=47 participants at risk
Participants received a single oral tablet of Placebo BID for 12 weeks.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/48 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
2.1%
1/47 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
ATI-450
n=48 participants at risk
Participants received a single oral tablet of ATI-450 50 mg BID for 12 weeks.
|
Placebo
n=47 participants at risk
Participants received a single oral tablet of Placebo BID for 12 weeks.
|
|---|---|---|
|
Nervous system disorders
Headache
|
12.5%
6/48 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
4.3%
2/47 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
6/48 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
8.5%
4/47 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
4.2%
2/48 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
6.4%
3/47 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.2%
3/48 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
6.2%
3/48 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
1/48 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
10.6%
5/47 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
2.1%
1/48 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
6.4%
3/47 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
8.3%
4/48 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
16.7%
8/48 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
10.4%
5/48 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
0.00%
0/47 • Baseline through Day 115
Safety population: All participants randomly assigned to study drug and who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place